Clinical Research:Patient-Centered Goals:Set by Who?: The Patients!
:
It was very interesting for me to read a Viewpoint
article in the June 12 2013
issue of the Journal of the American Medical
Association (JAMA). It has to do
with medical research and the role of patients in
that research. The article is
titled "Patient's Responsibility to Participate
in Decision Making and
Research" by Tinetti and Basch. One always
thinks that the role of the patient
in medical research should be simply as the
"guinea pig" or subject of the
research and that the creation and development of
the research project is the
job of the research scientists and physicians. It is
these professional folks
who are known to understand the science and the
missing information that needs
to be discovered and they are the ones to be
involved in deciding upon what and
how and to what ends a medical research study should
be designed.
However, on thinking about this a bit further about how
medical (also called
clinical) research is to be initiated, one should ask the
question as to whose
primary benefit should the research be directed. One could say that it is to
increase the pool of medical knowledge from which physicians
can access in
order to treat all their patients. A more cynical answer
would be that the
benefit can be self-serving and really provide a significant
benefit to the
professional both in terms of satisfaction of personal
inquisitiveness and, of
course, the opportunity to advance one's professional career.
The article, on
the other hand, stresses the importance of considering the
patients themselves
as the beneficiaries of medical research and as such it
should be the patients
themselves who should be involved in setting the basis for a
study and involved
in establishing what should be the study's goal. After all,
it is the patients
who can provide input into what patients want to get out of
the conclusion of
the research. This input could direct the research scientists
toward finding
results which would be more acceptable and needed from the
patient's point of
view.
Beyond the goal of the study, since the patients are the
"guinea-pigs" it would
seem ethical to allow some patient autonomy in the details of
the project to
have a say with regard to how they, as subjects, be utilized
and more
comfortable with the project. It is important to remember
that, in many aspects
of the study, there is a declared responsibility of the
patient to strictly
follow the directions set by the researchers and continue
their participation
since otherwise the study may be flawed or even lead to its
abandonment.
Therefore, patient participation in a study should extend
beyond being solely
the subjects to be experimented upon. As the title of the
JAMA article suggests
beyond being the subject, shouldn't patients in general be
required to
participate in medical research? However, also as the JAMA article
implies that
though there is general consensus about the responsibilities
of patients to
request information from physicians if they don't understand,
participate in
decision about diagnosis and treatment options and agree to
adhere to agreed-on
treatment program, "the responsibility of patients to
participate in research
is less clear than their responsibility to participate in
their own care." One
argument that could be made for patient responsibility would
be that "patients
have the duty to participate in research because everyone
benefits from the
results and the no one should be a 'free rider'"
Though, ideally, to achieve an effective goal of "patient-centered"
healthcare
and decision-making, the JAMA article concludes that to reach
that goal
requires that "patients let clinicians know their
priorities, understand which
strategies are most likely to achieve their priorities and
participate in
research which generates this evidence."
I would be interested to read what my visitors think about
the role of patients
to become a study research subject but also contribute to the
development of
patient-centered goals for the study. ..Maurice.
Graphic: From www.asbestos.com via Google Images
posted by Maurice Bernstein, M.D. @ 11:27:00 PM
2 comments
2 Comments:
Implied in the article but not stated is the fact that there is patient as individual person, and patient as member of society. Patient as individual would like to get well at almost any cost, and worried will the experimental treatment benefit herself. Patient as member of society is concerned that the research study be well-designed so that it yields unequivocal data at reasonable cost.Which patient is the one in "patient-centered"
Experiments are experiments because the outcome, though suggested by the results of previous experiments, is itself unknown and may not be known until the current experiment is completed, concluded and statistically evaluated. Often the patient "as an individual" and advocating for a person cure may not be fully aware or even aware at all that there is no reliable "cure" for that person nor for any person who desires a "cure" from the experiment. In a clinical experiment, most must start from a state of equipoise. That means that the experimental arm of the study has no better chance of yielding the desired outcome than the control arm. That is why the activity is called an experiment. Therefore, patients entering a clinical trial as individuals should consider themselves merely human subjects of the experiment and set only goals for the experiment that the protocol defines that they be treated humane ways as subjects and not simply objects of the experiment. Their interest therefore as individuals should be in that regard only.
For patients entering as members of society should look to, yes, the costs vs the achievement of the goals of the experiment. For that the patients need to know something of the competency and experience of the investigators and understand the goals of the experiment and their values and then be able to provide the "society" patient's view of what is planned before the experiment is started.
That means that experimental protocol be written to allow an opportunity for project education and the resultant feedback from patients both as individuals and members of society to the formulation of the final project.
This opportunity for patient feedback should be as an essential part of the structure of the research project as the further detailing regarding doses, timing, observational criteria and statistical analysis. Only in this way can "patient-centered goals" be said to have been considered whether as a individual patient or a member of society. ..Maurice.
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